FDA recall D-1185-2016

Medaus, Inc. · Class II · drug

Product

FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S. Nationwide, Japan, and New Zealand.

Key facts

Status
Terminated
Initiation date
2016-05-13
Report date
2016-07-20
Termination date
2017-06-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1185-2016